← Back to catalogue

EverFlex Self-Expanding Peripheral Stent System

FDA PMA

Class III (US FDA PMA)

PMA P110023

by Medtronic Vascular, Inc.

Identity

Trade Name
EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) FDA PMA
Generic Name
STENT, SUPERFICIAL FEMORAL ARTERY FDA PMA

Identifiers

PMA Number
P110023 FDA PMA
FDA Product Code
NIP FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The EverFlex Self-Expanding Peripheral Stent System is a medical device designed to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions. It is indicated for use in the native superficial femoral artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 to 7.5mm and lesion lengths up to 180mm.

The system is supplied as a sterile, single-use device and includes the EverFlex self-expanding stent with the Entrust delivery system. It is intended for use in vascular interventional settings and has received FDA PMA approval (P110023) for the specified indications.

Frequently asked questions

What is the EverFlex Self-Expanding Peripheral Stent System intended to treat?

The EverFlex Self-Expanding Peripheral Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal arteries, as stated in the approval documentation.

What are the size limitations for lesions treated with the EverFlex stent system?

The device is intended for lesions up to 180mm in length in arteries with reference vessel diameters ranging from 4.5mm to 7.5mm, based on the anatomical specifications provided in the approval statement.

Is the EverFlex stent system reusable or single-use?

The EverFlex Self-Expanding Peripheral Stent System is supplied as a sterile, single-use device, as indicated by its classification and typical configuration for vascular stent delivery systems in the provided data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rechtsinformation (RIS) - Bundeskanzleramt Österreich, RIS - Bundesrecht konsolidiert - Trefferliste, Rechtsinformationssystem - oesterreich.gv.at, RIS - Bundesrecht konsolidiert - Suche, RIS - Gesamtabfrage - Suche

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Vascular, Inc.

Sources (1)

  • FDA PMA P110023 24 fields · synced Sep 18, 2026